Over the past three months, the Medical Device Coordination Group (MDCG) has published further documents on the implementation of the Medical Device Regulation (MDR) .
In the following, we provide a brief summary of the content so that you can quickly find what concerns and/or interests you. We would also be happy to discuss our views on the content with you:
- MDCG 2019-7 Rev. 1: Guidance on Article 15 of the Medical Device Regulation Regulation (MDR) ... on the requirements for compliance with the legislation Person Responsible for Regulatroy Compliance (PRRC).
In addition to structural changes, the revision also contains important clarifications on the qualification and availability of the PRRC. - MDCG 2021-6 Rev. 1: Questions & Answers on clinical trials under MDR:
The revision contains numerous new questions and updated answers to questions already asked in implementation practice. - MDCG 2023-5: Guidance on the qualification and classification of Annex XVI devices (devices without an intended medical purpose):
This new document contains, among other things, important clarifications, including decision-making aids for products that are placed on the market in a dual manner, i.e. with and without an intended medical purpose. In addition, typical product examples are listed and justified. In our view, this is a very helpful document. Guidelines on the demonstration of equivalence for Annex XVI products. - MDCG 2023-6 Guidelines on the demonstration of equivalence for Annex XVI products:
This new document describes criteria to be considered in clinical evaluations using clinical data from equivalent devices. When can we speak of comparability and when is this questionable. In particular, it is clarified that in the case of dual equivalence products, i.e. products with and without a medical purpose, only the medical aspects are to be taken into account. - MDCG 2023-7: Guidance on exemptions from the obligation to conduct clinical trials under Article 61(4)-(6) MDR and on "sufficient access" to the data required as part of the equivalence justification:
This new document provides important guidance and decision-making recommendations for clinical evaluation when equivalence is claimed. Access to equivalence product data is a major problem in practice and a frequent point of contention with notified bodies. - MDCG 2024-1: Guidelines for the product-specific vigilance system for CE-marked products:
The aim of this product-specific vigilance guide is to harmonize vigilance reporting and provide guidance to manufacturers of specific products.- MDCG 2024-1-1: DSVG 01: Guidance on the harmonization of vigilance reporting for cardiac ablation devices
- MDCG 2024-1-2: DSVG 02: : Guidance on harmonization of vigilance reporting for coronary stents
- MDCG 2024-1-3: DSVG 03: : Guidance on harmonization of vigilance reporting for cardiac implantable electronic devices (CIEDs)
- MDCG 2024-1-4: DSVG 04: : Guidance on harmonization of vigilance reporting for breast implants
- MDCG 2024-2: Procedure for updating the European Medical Device Nomenclature (EMDN):
This process description explains how EMDN codes are created and released. It primarily serves to make the process described transparent.
These questions also arise again and again in our everyday lives. The decision in favour of a particular direction is often difficult to make and has a significant impact on the conformity assessment sverfahren. Wir helfen Ihnen gerne bei dieser Fragestellung und lassen unsere Erfahrung einfließen.
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